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ISRCTN
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ISRCTN76622877
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ClinicalTrials.gov identifier
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Public title
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The role of Oxidant Stress on the induction of the Inflammatory Reaction by Cardiopulmonary Bypass
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Scientific title
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Acronym
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N/A
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Serial number at source
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N0123138565
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Study hypothesis
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1. To study the mechanism by which inflammatory response to cardiopulmonary bypass is modulated by oxidant stress
2. To use an ex-vivo model of cardiopulmonary bypass (CPB) and blood samples from patients to investigate oxygen free radicals on the pathogenesis
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Ethics approval
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Not provided at time of registration
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Study design
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Randomised controlled trial
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Countries of recruitment
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United Kingdom
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Disease/condition/study domain
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Surgery: Cardiovascular
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Participants - inclusion criteria
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Patients with ischaemic heart disease (IHD) scheduled for elective cardiac operations will be selected.
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Participants - exclusion criteria
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Not provided at time of registration
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Anticipated start date
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05/12/2003
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Anticipated end date
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30/09/2006
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Status of trial
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Completed |
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Patient information material
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Target number of participants
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Not provided at time of registration
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Interventions
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The project is composed of laboratory based investigation and the molecular changes associated with the re-circulation of blood in an artificial surface will be studied using a surrogate model of CPB. A total of 400 patients will be randomised to one of the groups: IHD with and without Hypertension, IHD with and without Hypercholesterolemia, IHD with and without Diabetes, Healthy control.
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Primary outcome measure(s)
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Proinflammatory cytokines, antioxidant capacity, oxygen free radicals and clinical outcomes.
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Secondary outcome measure(s)
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Not provided at time of registration
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Sources of funding
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University Hospitals of Leicester NHS Trust (UK)
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Trial website
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Publications
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Contact name
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Dr
B
Matata
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Address
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University Hospitals of Leicester
c/o Research and Development Office
Leicester General Hospital NHS Trust
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City/town
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Leicester
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Zip/Postcode
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LE1 4PW
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Country
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United Kingdom
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Sponsor
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Record Provided by the NHSTCT Register - 2004 Update - Department of Health (UK)
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Address
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The Department of Health,
Richmond House,
79 Whitehall
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City/town
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London
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Zip/Postcode
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SW1A 2NL
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Country
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United Kingdom
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Tel
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+44 (0)20 7307 2622
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Email
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dhmail@doh.gsi.org.uk
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Sponsor website:
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http://www.dh.gov.uk/Home/fs/en
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Date applied
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30/09/2004
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Last edited
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15/02/2008
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Date ISRCTN assigned
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30/09/2004
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